Ann Arbor, MI, September 25, 2019 --(PR.com
)-- The National Institute of Health’s (NIH’s) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) has awarded Cayman Chemical with a Phase II Small Business Innovation Research (SBIR) grant to develop its patented small molecule bone repair agent KMN-159. Cayman will develop the compound as the active pharmaceutical ingredient (API) of a drug-device combination that accelerates bone regrowth for healing recalcitrant fractures in the aging population.
“Approximately 6.3 million fractures occur in the United States each year, accounting for 16% of all musculoskeletal injuries and leading to well over 10 million hospital and physician office visits,” said Dr. Inés Morano, Director of Discovery R&D at Cayman. “We seek to address this unmet need by developing and commercializing a new small molecule-based, locally administered drug-matrix combination for at-risk elderly fracture patients.”
“Over the course of two years, we plan to demonstrate dose-dependent efficacy of KMN-159 in a model using young and old rats from the National Institute on Aging (NIA) rodent colony,” said Stephen Barrett, Vice President of R&D and Production at Cayman. “The grant will also fund initiation of CGMP manufacture process development and production of the first CGMP batch of the KMN-159 API. The API combined with a commercial 510(k)-approved bone matrix will comprise the drug-device combination we will assess for safety in a GLP rabbit study. We hope that the efficacy and safety data we generate during this NIH-funded phase of program development will provide a firm basis for FDA Investigational New Drug (IND) application and a subsequent First-in-Human (FIH) study enrolling patients suffering from the burdens of delayed and non-union fractures (DNFs).”
The grant includes a subaward for animal studies being conducted at the Department of Orthopaedic Surgery at the University of Michigan under the direction of Dr. Kenneth Kozloff. In addition to general fracture repair, this pivotal research may be applicable to orthopedic, periodontal, or craniofacial disorders. The key innovation to Cayman’s EP4 agonist program approach lies in its design for local administration of compound via an FDA-approved matrix as a drug-device combination. Successful outcome of these studies will lead to the possibility to advance to FIH clinical studies.